This current study aims to investigate the use of bèta-TCP, a synthetic tricalcium phosphate, as a filler of the autologous symphyseal bone graft harvest site in patients undergoing grafting of clefts of lip, alveolus and palate.The specific…
ID
Source
Brief title
Condition
- Other condition
- Congenital and hereditary disorders NEC
- Head and neck therapeutic procedures
Synonym
Health condition
cheilognathopalatoschisis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome of the study will be the difference(%) in volumetrically(sq mm)
assessed bone volume compared to the original bone volume.
Secondary outcome
not applicable
Background summary
At approximately 11 years of age patients with cleft of lip, alveolus and
palate will undergo bonegrafting surgery in order to close the alveolar cleft
with autologous chin bone or with iliac crest bone before orthodontic
interference takes place. These harvest sites require a second additional
surgical procedure with risk of primary and secondary complications. Therefore
the use of a synthetic, osteoinductive material seems a logical step forward.
Study objective
This current study aims to investigate the use of bèta-TCP, a synthetic
tricalcium phosphate, as a filler of the autologous symphyseal bone graft
harvest site in patients undergoing grafting of clefts of lip, alveolus and
palate.
The specific properties of Progentix TCP result in optimal and predictable bone
regeneration as also proven in the human situation.
It seems meaningful to introduce the bèta-TCP first of all in the harvest site
in which bone has to be regenerated and no orthodontic interference will be
performed.
Study design
-indication for grafting the alveolar cleft in the patient with cleft of lip,
alveolus and palate at the age of 9-13 years, set by the orthodontist and the
oral surgeon. Usually the decisive moment for surgery depends on the
developmental stage of the upper canine root.
-taking of lateral cephalometric radiographs, immediately before and after the
surgical harvesting/grafting-procedure and three, six, and twelve months
postoperatively as is already the protocol.
-assessment of volumetric measurements from lateral cephalometric radiographs.
-statistics.
Intervention
In all participants in this study the bèta-TCP will be used as a filler of the
donorsite where the autologous chin bone is harvested.
The outcome of this study will be compared to the results of a retrospective
study where Lyostipt(spongegel) was used as a filler of the donorsite.
Study burden and risks
Burden and risks and x-ray diagnostics for this group of test subjects do not
differ from standard treatment.
Heidelberglaan 100
3584 CX U T R E C H T
NL
Heidelberglaan 100
3584 CX U T R E C H T
NL
Listed location countries
Age
Inclusion criteria
Children with cleft of lip, alveolus and palate with radiological proof of half-developmental stage of the root of the upper canine
Exclusion criteria
No cleft of lip and palate
No symphyseal bonegraft
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13880.041.06 |